Director, Regulatory Affairs in Basking Ridge, NJ at DSI

Date Posted: 9/10/2020

Job Snapshot

Job Description

Join a Legacy of Innovation 110 Years & Counting!

With over 100 years of scientific expertise & a presence in more than 20 countries, Daiichi Sankyo & its 15,000 employees around the world draw upon a rich legacy of innovation & a robust pipeline of promising new medicines to help people. In addition to a strong portfolio of medicines for hypertension & thrombotic disorders, under the Group’s 2025 Vision to become a “Global Pharma Innovator with a Competitive Advantage in Oncology,” Daiichi Sankyo research & development is primarily focused on bringing forth novel therapies in oncology, including immuno-oncology, with additional focus on new horizon areas, such as pain management, neurodegenerative diseases, heart & kidney diseases, & other rare diseases.

Job Summary:

Effectively liaise, negotiate and partner with FDA; direct, coordinate and implement the preparation of all regulatory submissions and provide regulatory support across all global projects, securing the cooperation of others (team members); meet aggressive deadlines to ensure that regulatory agencies receive timely and quality submissions, shortening the review process and leading to successful approval of pharmaceutical applications for the company’s growth, thereby accomplishing corporate goals.

Responsibilities:

Liaise, negotiate and orchestrate meetings and teleconferences with FDA; strategize and plan for FDA meetings; capture all communications via contact reports.

Prepare, assemble and publish all regulatory documents (NDAs, INDs, Annual Reports, Safety Updates, Quarterly Reports) in paper and electronic format.

Participate in global product team meetings (development and marketed products); provide regulatory support and guidance and manage day-to-day regulatory activities.

Collaborate with all disciplines within the Daiichi Sankyo organization to obtain and/or provide information/data for regulatory filings.

Mentor/instruct and provide guidance to direct reports.

Review and interpret regulatory guidelines.

Review RA and related documents for approval.

Continuing Education: Keep current with regulations and guidance documents; attend meetings, seminars, conferences on relevant topics; read journals, newsletters, scientific papers; research the answers to RA questions.

Qualifications: Successful candidates will be able to meet the qualifications below with or without a reasonable accommodation.

Education/Experience:

BS degree in chemistry, biology or other related scientific discipline required. Masters, PhD or PharmD highly desired.

10+ years in the pharmaceutical industry. 5+ years in global regulatory affairs, NDA, sNDA, BLA filing to FDA considered a plus.

Daiichi Sankyo, Inc. is an equal opportunity/affirmative action employer. Qualified applicants will receive consideration for employment without regard to sex, gender identity, sexual orientation, race, color, religion, national origin, disability, protected veteran status, age, or any other characteristic protected by law.